FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
K Number: K173874
·
Decision May 4, 2018
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
3
Review Days
134
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
- K Number
- K173874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Origami Surgical, LLC
- Date Received
- December 21, 2017
- Decision Date
- May 4, 2018
- Product Code
- GAM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAM), ordered by most recent decision date.
Trexon Monofilament Synthetic Absorbable Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TroClose 1200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Monotime and Optime R
FDA 510(k)
FDA Class 2
·General, Plastic Surgery